FreMon Scientific filed a 510(k) application with the FDA for ZipThaw202 and ZipSleeve.
FDA reviewers have already asked several pages of pertinent questions which have now been answered by our team. Others inquiries are sure to follow. QSite Consultants and the law firm of Mintz Levin are providing keen guidance for ZipThaw202 and ZIpSleeve. We look forward to continuing this productive process with the FDA.